Responsible for day-to-day adverse experience case management within the country(ies) covered by the country operation including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per client’s procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements. Responsible for aggregate safety report submissions in the country(ies) in accordance with Global Safety procedures and health authority requirements. Responsible for the reconciliation of adverse events reports received from other Merck operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable Responsible for the filing, storage and archiving of safety-related data in accordance with client’s policies and local requirements. Serve as the local Deputy Qualified Person for PV (QPPV) / deputy local responsible PV person for the country(ies) when delegated by PV Country Lead. Serve as back-up in the absence of the PV Country Lead to ensure business continuity. Responsible for being compliant with local PV regulations, client policies and procedures and Global Safety procedures at the country level. Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the country(ies) covered by the country operation. Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection. Identify and communicate potential safety issues to PV Country Lead. Assist in the delivery of training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors / business partners in the country(ies) within scope. Complete and document required PV training within the required timelines. Perform other activities as requested by the PV Country Lead.
The incumbent must have a health, life science, or medical science degree or equivalent by education / experience.
He/she should have at a minimum 1 year of pharmaceutical industry experience. He/she must have an awareness of Pharmacovigilance regulations within his/her assigned country(ies). The PV Specialist is expected to have strong communication and time management skills, and have the ability to work independently with minimal supervision.